Environmental Protection Agency (U.S.)

The United States Environmental Protection Agency (EPA) was established in 1970 to centralize and coordinate federal efforts to assess, prevent, and remediate the adverse impacts of human activities on natural systems and human health. Its scope has grown and shifted in the intervening decades to include themes such as pollution prevention and green chemistry, which emphasize the development of technologies and production systems environmentally friendly by design.

According to the “AAAS [American Association for the Advancement of Science] Report XXXIV: Research And Development FY [fiscal year] 2010,” $18 million was requested for EPA to study the health and environmental implications of nanomaterials, which is a $2 million increase from the FY 2009 estimate.

The emergence of nanoscale science and engineering challenges EPA in both its regulatory and research capacities. It is not clear whether existing legislation gives the agency the tools it needs to fulfill its mission with respect to nanotechnologies, and nanomaterials raise some profound metrological questions. In terms of research, the current state of knowledge includes significant gaps, which EPA's draft strategy identifies and prioritizes in order to guide their activities through 2012. In summary, the combination of regulatory and scientific uncertainty surrounding nanomaterials will present the agency with both problems and opportunities for the foreseeable future.

EPA derives its regulatory authority from a number of statutes, many of which are media specific (air, water, soil). In terms of engineered nanomaterials, the Toxic Substances Control Act (TSCA) is most relevant. TSCA differentiates between “new” and existing chemicals, and classifying nanosubstances within this framework has been problematic. The agency has recently clarified that it considers novel carbonaceous materials (e.g., carbon nanotubes and buckyballs) as “new,” meaning that such materials are subject to stricter regulation.

The status of materials whose chemical structure is similar at the bulk and nanoscales, such as titanium dioxide, which is commonly used in sunscreens and other applications, remains unclear. EPA has initiated a voluntary reporting program under TSCA, the Nanomaterials Stewardship Program (NMSP), in order to [Page 208]bolster its databases, and intends to use the results from this pilot effort to inform future data call-ins.

Several additional pieces of legislation may be relevant to nanomaterials. EPA has taken action under the Federal Insecticide, Rodenticide, and Fungicide Act (FI-FRA) to require pre-market approval of nanosilver as an antibacterial agent in washing machines. To the degree that the release of nanoparticles into the environment becomes commonplace, whether intentionally or otherwise, the various acts that govern clean air, water, drinking water, and soil could come into play. Generally speaking, the agency's authority under the relevant legislation is focused on setting appropriate exposure levels for particular substances, and monitoring compliance. How nanomaterials will fit into these frameworks remains to be seen.

In support of its broader missions, EPA's Science Policy Council convened an agency-wide working group on nanotechnologies in 2004. EPA personnel collaborated with the array of government entities involved in the National Nanotechnology Initiative (NNI), particularly the Nanotechnology Environmental and Health Implications (NEHI) working group to produce at least two relevant research strategy documents. The agency has also published a white paper on the subject, and most recently, a research strategy for public comment.

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